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Top Articles - Remarks By Elbaradei Encourage Iran To Pursue Nuclear Ambitions
Mr. ElBaradei, in a surprising remark, has invited the international community to accept the fact that Iran has now achieved nuclear know-how and can produce enriched uranium at
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
industrial levels. Such remarks, from someone at ElBaradei's position, are nonconstructive and can not help in any way but to embolden the Iranian regime to continue its defia
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
nce.
The International Atomic Energy Organization (IAEA) recently-published report stresses that not only has the Iranian regime defied the United Nations Security Council Reso
The International Atomic Energy Organization (IAEA) recently-published report stresses that not only has the Iranian regime defied the United Nations Security Council Reso
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
lutions 1696, 1737 and 1747 calling for the immediate suspension of its uranium enrichment program, it has also started up and expanded the production of its centrifuges. The Ir
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
nian mullahs have utilized at least 1,300 centrifuges to enrich uranium on a much larger scale.
Moreover, in recent weeks, the mullahs’ Supreme Leader Ali Khamenei and Iran’s h
Moreover, in recent weeks, the mullahs’ Supreme Leader Ali Khamenei and Iran’s h
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ard-line President Mahmoud Ahmadinejad have repeatedly stated that the regime will press ahead and will not back away even one step from pursuit of nuclear program and uranium e
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
nrichment.
Iran’s defiance continues despite extensive offers by the West of concessions and incentives and expressions of will to negotiate with the regime.
The Iranian regim
Iran’s defiance continues despite extensive offers by the West of concessions and incentives and expressions of will to negotiate with the regime.
The Iranian regim
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
knows for a fact that with all the developments in the region and the troubles it faces at home, its only chance for survival is to acquire nuclear weapons and spread its rule
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
in Iraq and the rest of the Middle East.
Preventing the realization of a nuclear armed Iran is still possible. But we must act and we must act quickly. What the situation req
Preventing the realization of a nuclear armed Iran is still possible. But we must act and we must act quickly. What the situation req
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
uires is not more flexibility towards the mullahs. On the contrary we need to have a firm stance in dealing with them.
Mr. ElBaradei’s comments to allow the Iranian mullahs to
Mr. ElBaradei’s comments to allow the Iranian mullahs to
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
have some degree of uranium enrichment do not serve this purpose.
Mr. ElBaradei’s responsibility at the IAEA is to ensure that the Iranian regime will not acquire nuclear weapo
Mr. ElBaradei’s responsibility at the IAEA is to ensure that the Iranian regime will not acquire nuclear weapo
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ns. The stance he takes is very sensitive and important and should not be politically or otherwise motivated.
Unfortunately during the past few years, ever since the existence
Unfortunately during the past few years, ever since the existence
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
of a clandestine nuclear program in Iran has been exposed, Mr. ElBaradei has failed to help prevent further progress of the program. His weak stance has actually hindered a pr
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
eventive measure to be adopted by the United Nations and the international community. Now he says that Iran has reached the point of no return, so it must be tolerated.
It mus
It mus
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
be known and understood that the Iranian mullahs are in fact perusing a military goal in their nuke program. One must keep in mind that there was not a need to conceal develop
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
ment of a peaceful nuclear program for 18 years just to come to light by the Iranian oppositions, the National Council of Resistance of Iran. Throughout the 18 years, the exten
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
t of the cover-up and the size of the program are considerable.
Furthermore, Iran by now could have easily diverted the current international pressures if it did not have any m
Furthermore, Iran by now could have easily diverted the current international pressures if it did not have any m
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
litary ambitions.
To understand the impact of such remarks by Mr. ElBaradei, we need not look much far. All we have to do is to see who is encouraged here.
Iran’s Foreign Min
To understand the impact of such remarks by Mr. ElBaradei, we need not look much far. All we have to do is to see who is encouraged here.
Iran’s Foreign Min
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
ister Manouchehr Mottaki praised ElBaradei for his remarks. "Naturally we approve of part of ElBaradei's comments and that is admitting to Iran's nuclear capacity and Iran's en
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
try to industrial nuclear fuel production. We are happy that ElBaradei as someone who is in charge of the nuclear question has acknowledged these issues," Mottaki told reporters
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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